Acute coronary syndrome: lamifiban did not reduce major cardiac events

Clinical bottom line (level 1b)

  1. Patients with acute coronary syndrome who received lamifiban compared with placebo were not less likely to have die, have a myocardial infarction or severe recurrent ischaemia
Newby et al: Circulation 2001; 103 : 2891-2896
PARAGON-B investigators : Circulation 2002; 105 ( 3 ): 316-321
Expires May 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 389 acute hospitals, 29 countries

5225 patients (aged 54 to 73; mean 64, 65% male) with acute coronary syndrome
  • symptoms lasting for at least 10 minutes within previous 12 hours
  • ECG changes, but no ST elevation; or elevated CK-MB or troponin T or I


Excluded if
  • aged < 21
  • contraindication to aspirin or heparin
  • increased bleeding risk
  • planned or recent thrombolysis
  • use of other GP IIb/IIIa therapy
  • recent major surgery
  • estimated creatinine clearance < 30 ml/min

Control Group: (n = , analysed): placebo
Experimental Group: (n = , analysed): lamifiban bolus 500 microg, followed by an infusion adjusted for renal function to achieve a steady state concentration of 18 to 42 ng/ml for 72 hours
All patients received aspirin and heparin.
100% followed for 30 days

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death, myocardial infarction or severe recurrent ischaemia 30 days
(12.8%)
(11.8%)		 8%
(-7% to 20%)		 1.00%
(-0.78% to 2.78%)		 100
(NNT = 36 to infinity;
NNH = 130 to infinity)

Citation

  1. Newby LK, Ohman EM, Christenson RH, et al: benefit of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes and troponin T-positive status: the PARAGON-B troponin T substudy. Circulation 2001; 103 : 2891-2896
  2. PARAGON-B investigators , : randomized, placebo-controlled trial of titrated intravenous lamifiban for acute coronary syndromes. Circulation 2002; 105 ( 3 ): 316-321
Search Terms:
Contributor: , May 2002
Reviewer:

Clinical Question.
Patient acute coronary syndrome
Intervention or Exposure lamifiban
Comparison placebo
Outcome death, myocardial infarction, severe recurrent ischaemia